(147 days)
The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
The Ranfac Aspiration Needle with Adjustable Guide consists of a stainless steel cannula, and two stainless steel stylets. All of the aforementioned have handles molded of ABS plastic. The cannula has an Adjustable Guide, also molded of ABS plastic that can be used as a depth guide.
This document is a 510(k) premarket notification for a medical device, specifically the Ranfac Aspirating Needle with Adjustable Guide. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a clinical study with acceptance criteria for device performance in a diagnostic accuracy context.
Therefore, many of the requested details about acceptance criteria for device performance, a specific study proving it, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of submission. This document highlights the device's physical and material characteristics, its intended use, and its adherence to relevant manufacturing and sterilization standards.
Here's the breakdown of what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided in this document. This submission focuses on demonstrating substantial equivalence through comparison of materials, design, technological characteristics, and adherence to standards, not on clinical performance metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance
Not applicable. No diagnostic accuracy test set is described. The "test" here refers to non-clinical testing against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for diagnostic accuracy is established as this is not a diagnostic device with performance claims.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, nor is it a diagnostic imaging device typically associated with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (an aspiration needle), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" in this context relates to meeting engineering and biocompatibility standards.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Information that can be extracted related to the device and its "acceptance":
While there isn't a table of clinical acceptance criteria and performance as you'd find for a diagnostic algorithm, the document does describe criteria for the device's design, materials, and manufacturing, and states that these criteria are met. This is implicitly the "acceptance criteria" for this type of device and submission.
"Acceptance Criteria" and "Study Proving Acceptance" (as interpreted from the document for a physical device):
| Acceptance Criteria (Standards Adherence) | Reported Device Performance (Claimed Conformance) |
|---|---|
| Material Composition: Stainless steel needle tubing for medical devices. | Conforms to ISO 9626 First edition 1991-09-01, Amendment 1 2001-06-01 (Stainless steel needle tubing for the manufacture of medical devices. FDA Standards Recognition Number 6-163). |
| Luer Lock Connection: Conical fittings with a 6% (Luer) taper - General requirements. | Conforms to ISO 594/1 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. FDA Standards Recognition Number 6-11). |
| Luer Lock Connection: Conical fittings with a 6% (Luer) taper - Lock fittings. | Conforms to ISO 594-2 Second edition 1998-09-01 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. FDA Standards Recognition Number 6-129). |
| Sterilization Process: Requirements for development, validation and routine control of a sterilization process. | Conforms to ISO 11135-1 (Sterilization of health care products -Ethylene Oxide - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices. FDA Recognition Number 14-331). |
| Sterilization Residuals: Biological evaluation of medical devices - Ethylene oxide sterilization residuals. | Conforms to ISO 10993-7 (Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals. FDA Recognition Number 14-278). |
| Biological Indicators: Guidance for selection, use and interpretation of results for sterilization. | Conforms to AAMI/ANSI/ISO 14161:2009 (Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results. FDA Recognition Number 14-285). |
| Packaging: Requirements for materials, sterile barrier systems and packaging systems for terminally sterilized medical devices. | Conforms to ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA Recognition Number 14-355). |
| Intended Use & Technological Characteristics: Similarities to predicate devices. | The Ranfac Aspiration Needle with Adjustable Guide is similar in materials and design to the predicate devices (K131157, K121181), comprising stainless steel cannula and stylets with plastic handles and luer fittings for standard piston syringes. Its intended use (aspiration of bone marrow or autologous blood) is also consistent. |
Study that proves the device meets the acceptance criteria:
The document states that the "Non-clinical Data: Standards" section indicates compliance. The "study" isn't a single traditional clinical trial but rather the demonstration of adherence to specified international and national standards relevant to medical device manufacturing, materials, and sterilization. This involves testing and validation performed by the manufacturer to ensure the device meets the requirements of these standards. The conclusion explicitly states: "Based on the similarities in materials, design, principles of function, biocompatibility and sterilization between the Ranfac Aspiration Needle with Adjustable Guide, subject of this premarket notification and the predicate devices, the Ranfac Aspiration Needle with Adjustable Guide has been shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act." This "showing" is the proof for this type of submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2014
Ranfac Corporation Mr. Christopher P. Whelan Senior Vice President 30 Doherty Avenue Avon, Massachusetts 02322
Re: K140991
Trade/Device Name: Ranfac Aspirating Needle with Adjustable Guide Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: September 2, 2014 Received: September 3, 2014
Dear Mr. Whelan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Radiological Health
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140991
Device Name
Ranfac Aspirating Needle with Adjustable Guide.
Indications for Use (Describe)
The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
Type of Use (Select one or both, as applicable)
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY CONTR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows a logo for a company called Ranfac. The logo is split into two halves, with the left half being black and the right half being white. The word "Ranfac" is written in black letters above the logo. The logo is a semi-circle shape.
SECTION 5
K140991 510(k) Summary
The contents of this 510(k) summary on the following pages have been provided in conformance with 21 CFR § 807.92 Content and format of a 510(k) summary.
510(k) Summary
Owner's Name and Address:
Official Contact Person:
Date Summary Prepared:
Device Trade Name:
Common Name:
Classification Name:
Ranfac Corp. 30 Doherty Avenue Avon, MA 02322-0635 FDA Registration Number 1211566
Christopher P. Whelan Senior Vice President Telephone: 508-588-4400 extension: 106 Facsimile: 508-584-8588 e-mail: cwhelan@ranfac.com
April 15, 2014
Ranfac Aspiration Needle with Adjustable Guide
Needle, Aspiration and Injection, Disposable
Gastroenterology-urology biopsy instrument (KNW) Subpart B Diagnostic Devices 21 CFR § 876.1075, Gastroenterology-urology biopsy instrument, Class II
510(k) Summary
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA 800-272-6322 | Fax: 508-584-8588 Phone: 508-588-4400 -Email info@ranfac.com
sincc 1888
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Image /page/4/Picture/0 description: The image shows a logo with the text "Ranfac" on the top right. There is a horizontal line above the text. Below the text is a semi-circle that is split in half, with the left half being black and the right half being white.
510(k) Summary
Predicate Device:
| 510(k)Number | Predicate Description | Manufactured By |
|---|---|---|
| K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac Corp. |
| K121181 | SwannShidi Bone Marrow Aspiration Needle | Alliance Partners, LLC |
Background
The Ranfac Aspiration Needle with Adjustable Guide is a variation of the Ranfac Bone Marrow Aspiration Needle (K131157). The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe. The Ranfac Aspiration Needle with Adjustable Guide works in a similar manner to the Ranfac Bone Marrow Aspiration Needle in that it enters the bone by the user applying pressure to the needle/stylet while twisting the handles. Once the needle enters the marrow cavity, the Stylet is removed and a Blunt Stylet is inserted and the needle is advanced to the desired location as set by the Adjustable Guide. Aspiration is performed by attaching a syringe to the Luer fitting of the needle and applying negative pressure. The needle can be partially withdrawn to continue to aspirate from different areas prior to complete withdrawal.
Device Description:
The Ranfac Aspiration Needle with Adjustable Guide consists of a stainless steel cannula, and two stainless steel stylets. All of the aforementioned have handles molded of ABS plastic. The cannula has an Adjustable Guide, also molded of ABS plastic that can be used as a depth guide.
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Fax: 508-584-8588 800-272-6322 || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || Phone: 508-588-4400 Email info@ranfac.com
sincc 1888
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Image /page/5/Picture/0 description: The image shows a logo with the text "Ranfac" at the top. Below the text is a semi-circular shape that is divided vertically into two halves. The left half of the semi-circle is filled with a solid black color, while the right half is white with a black outline.
510(k) Summary
The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
The Ranfac Aspiration Needle with Adjustable Guide is similar in materials and design to the predicate devices. All devices are comprised of stainless steel cannula and stylets with mating plastic handles. All devices have luer fittings enabling the use of standard piston syringes.
The Stainless Steel Cannula and Stylets, contact the patient in a limited use, and is in conformance with ISO 9626 First edition 1991-09-01, Amendment 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devices. FDA Standards Recognition Number 6-163.
The luer lock connection that is molded as part of the plastic handle is in conformance with ISO 594/1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. FDA Standards Recognition Number 6-11.
The luer lock connection that is molded as part of the plastic handle is in conformance with ISO 594-2 Second edition 1998-09-01, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. FDA Standards Recognition Number 6-129.
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Phone: 508-588-4400 | 800-272-6322 | Fax: 508-584-8588 Email info@ranfac.com
Intended Use:
Technological Characteristics:
Non-clinical Data: Standards
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Image /page/6/Picture/0 description: The image shows a logo for a company called Ranfac. The logo is a semi-circular shape that is divided into two halves. The left half is filled with black, and the right half is white. The word "Ranfac" is written in a sans-serif font above the semi-circle.
The following standards apply to the sterilization of the finished device.
ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices. FDA Recognition Number 14-331.
ISO 10993-7, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals. FDA Recognition Number 14-278.
AAMI/ANSI/ISO 14161:2009, Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results. FDA Recognition Number 14-285
ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. FDA Recognition Number 14-355
Not applicable
Clinical Data:
Conclusion:
Based on the similarities in materials, design, principles of function, biocompatibility and sterilization between the Ranfac Aspiration Needle with Adjustable Guide, subject of this premarket notification and the predicate devices, the Ranfac Aspiration Needle with Adjustable Guide has been shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
RANFAC CORP. | PO BOX 635 | 30 DOHERTY AVE | AVON, MA 02322 | USA Phone: 508-588-4400 | 800-272-6322 | Fax: 508-584-8588 | Email info@ranfac.com
since 1888
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.